UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045196 |
|---|---|
| Receipt number | R000051555 |
| Scientific Title | Hair thinning improvement effect evaluation test of hair restorer |
| Date of disclosure of the study information | 2021/08/19 |
| Last modified on | 2022/08/17 10:29:20 |
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Basic information
Public title
Hair growth trial
Acronym
Hair growth trial
Scientific Title
Hair thinning improvement effect evaluation test of hair restorer
Scientific Title:Acronym
Hair growth trial
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to verify the effect of the product on hair growth in a 24-week continuous use test in healthy adult males and females with symptoms of thinning hair.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Photo Trichogram (Growth rate, Hair diameter, Anagen hair percentage,Hair number)
Key secondary outcomes
Stratum corneum water content of the scalp,Questionnaire survey,Head photography (front side of head, back side of head),Adverse event investigation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Subjects use the test product twice daily for 24 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[1]Healthy Japanese males and females aged between 30 and 60 at the time of informed consent
[2]Subjects with feeling of thinning hair and hair loss
[3]Subjects who don't have full head of gray hair or are dyeing gray hair
[4]Subjects who can agree to cut hair locally approximately 1.0 cm x 1.0 cm near the crown on each visit day
[5]Subjects who can agree to keep the conditions such as hair conditioning and hair dyeing constant on each visit day
[6]Subjects who can obtain written consent at their own discretion before the study begins
Key exclusion criteria
[1]Subjects with pathological hair loss such as alopecia areata
[2]Subjects with scalp diseases other than hair loss (eg, head eczema, seborrheic eczema, psoriasis, tinea capitis, and other scalp infections)
[3]Subject with reduced or abnormal thyroid function
[4]Subjects with photosensitivity disorder
[5]Subjects receiving "hormone replacement therapy" or taking oral contraceptives within one year
[6]Subjects who are pregnant or lactating, or who intend to become pregnant
[7]Subject with atopic dermatitis
[8]Subjects who habitually apply or take external preparations, oral medicines, supplements, etc. that may affect the condition of the head
[9]Subjects with a history of hypersensitivity (allergies) to hair growth agents, hair restorer, cosmetics (shampoo, etc.), or hypersensitivity to other medicines.
[10]Subjects who have been treated with radiation therapy to the head or cancer chemotherapy within the last 6 months, or who will be treated within the next 2 months after the end of the study
[11]Subjects who regularly use wigs during the study period, subjects who have undergone hair transplantation or hair growth, or subjects who are scheduled during the study period
[12]Subjects who have been treated with pharmaceutical hair growth agents (such as finasteride, minoxidil, or carpronium chloride-containing preparations) within the past 6 months
[13]Subjects who have used existing hair growth agents and hair restorer within the past 2 months, regardless of whether they are pharmaceutical products or quasi-drugs.
[14]Subjects currently using medical medications known to cause trichotillomania or hirsutism (eg, phenytoin for epilepsy)
[15]Subjects working for cosmetics companies and pharmaceutical companies
[16]Subjects judged to be ineligible for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Yonei |
Organization
Faculty of Life and Medical Sciences,Doshisha University
Division name
Anti-Aging Medical Research Center
Zip code
610-0394
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774-65-6394
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Yamamura |
Organization
Nikoderm Research Inc.
Division name
Evaluation Division
Zip code
541-0052
Address
1-6-14 Azuchimachi,Chuo-ku,Osaka City, OSAKA, Japan
TEL
06-6125-3501
Homepage URL
myamamura@nikkolgroup.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Society of Glycative Stress Research
Address
5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-6709-8842
rinri-glycativestress@antiaging-bank.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社ニコダームリサーチ（大阪府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
27
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 19 | Day |
Last modified on
| 2022 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051555
